The Research Ethics Committees (RECs) at the University of Waterloo and the Research Ethics Board (REB) at Wilfrid Laurier University (WLU) have established an alternative review model for research involving investigators from both institutions.
The establishment of this coordinated review process is in accordance with the Tri-Council Policy Statement, 2nd edition (TCPS2), outlining institutions may adopt an alternate review model for multi-jurisdictional research. Both institutions however will, as outlined in the TCPS2, “remain responsible for research undertaken within its jurisdiction or under its auspices irrespective of where the research is conducted” (TCPS2, Article 8.1).
The objective of this coordinated review process is to streamline the ethical review process for Waterloo and WLU researchers by providing a single point of contact at their home institution. The coordination of simultaneous review is expected to eliminate the need for consecutive review at both institutions and reduce the time researchers experience obtaining ethics clearance for multi-site research. This process is also expected to aid researchers in handling comments made by one REB/REC that then requires approval as a modification to another REB/REC.
It is expected that the Waterloo-WLU coordinated review process will continue to evolve over time as outlined in the Ethic Review Agreement between the two institutions. Future changes to this process shall be made by mutual agreement between the REBs/RECs and review of this agreement will be undertaken annually.
A researcher submitting an application for the coordinated review process agrees that all information provided, or later requested to be provided, can be freely shared between the REBs/RECs.
All research regardless of the risk level identified is eligible for the Waterloo-WLU coordinated review process.
- For technical reasons the Waterloo research ethics application form will be used to apply for ethics clearance under this process. This form, along with any accompanying documentation, will be submitted to the REB/REC at the lead researcher's institution (either WLU or Waterloo)
- REB/REC administrators at the home institution of the lead researcher will assume primary responsibility for coordinating the review process
- The submitted application will be reviewed simultaneously by a delegated reviewer identified by each institution’s REB/REC
An REB administrator at each institution will provide the applicant(s) with a single set of comments from the delegated reviewers at both REBs/RECs
Both REBs/RECs will create and maintain a complete file on each application submitted for joint review (e.g., reviewer names, reviewer comments, revised applications forms, etc.) within their respective database or filing systems
The revised application will be reviewed by REB/REC administrators at both institutions to verify that all requested changes have been made to their satisfaction
When the REB/REC delegated reviewers at both institutions agree that REB/REC approval can be granted, the REB/REC at the lead investigator's home institution will issue the coordinated ethics clearance notification. This notification outlines that approval was obtained via a coordinated approval process between the WLU REB and a Waterloo REC.
Requests for modifications/amendments to an approved and active research study that was reviewed through the coordinated review process will be reviewed by the REB/REC at both institutions using the WLU amendment form. Notification of research ethics clearance for a modification will be sent by WLU on behalf of both REBs/RECs.
- Continuing review and renewal of an active research project that was reviewed through the coordinated review process must be submitted by the lead researcher to both the WLU REB and the Waterloo REC using the required forms
- Researchers must report all problems that occurred in the research:
- Adverse events of research that was reviewed through the coordinated review process must follow the usual process for reporting adverse events as outlined by each REB/REC. The lead researcher is responsible for notifying their home institution REB/REC then immediately following up with the other REB/REC
- Protocol deviations of research that was reviewed through the coordinated review process must follow the usual process for reporting protocol deviations as outlined by each REB/REC. The lead researcher is responsible for notifying their home institution REB/REC then following up with the other REB/REC
Researchers are to contact their research ethics office/administrator to discuss the application being submitted for review.